NCT04522479

Prolonged Protocol of Early Follicular or Mid Luteal Phase

Comparison of Efficacy and Safety of Controlled Hyperstimulation of Prolonged Protocol in Early Follicular or Mid Luteal Phase: a Single Center, Randomized, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,150 (estimated)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

Due to the injection of gonadotropin releasing hormone agonist (GnRH-a) before controlled ovarian hyperstimulation (COH), the scheme of prolonged early follicular period protocol has obvious advantages in achieving ideal egg number, increasing endometrial receptivity to embryo transfer, inhibiting endogenous luteinizing hormone (LH) peak and reducing cycle cancellation rate. The full dose of long acting GnRH-a was also applied before COH in the mid luteal Hypergrowth program, and the mechanism of its lowering tone was similar. But whether the clinical and perinatal outcome of early follicular hyperlengthening is as effective as that of mid luteal hyperlengthening has not been reported at home and abroad. Moreover, there is a lack of prospective randomized controlled studies.

Detailed description

One injection of 3.75mg GnRHa was injected on the 1st-3rd or 21st-23rd day of menstruation. The level of estradiol (E2), progesterone (P), luteinizing hormone (LH) in peripheral blood and the number of follicles in bilateral ovarian internal sinuses were monitored on the 32nd-38th day after pituitary hyporegulation.Gonadotropin (Gn) will be given after pituitary desensitization. When the diameter of at least two follicles ≥ 18mm or more than three follicles ≥ 17mm, the trigger of human chorionic gonadotropin (hCG) will be given and oocyte will be retrieved. The selective fresh single blastocyst transplantation will be carried out on the 4th-6th day after oocyte retrieval. HCG test at 12nd day after transplatation. Follow-up investigation will given during the pregnancy and perinatal period.

Conditions

• IVF

Interventions

Type	Name	Description
OTHER	Change the injection time of long acting GnRH-a	The whole dose of long acting GnRH-a drug was changed to be injected on day 21st-23rd day of menstruation

Timeline

• Start date: 2020-05-13
• Primary completion: 2023-05-13
• Completion: 2024-05-13
• First posted: 2020-08-21
• Last updated: 2020-08-21

Locations

1 site across 1 country: China